Breast Implant Safety

Breast implants are obviously man-made medical devices and, unfortunately, there is no such thing as a perfect medical device. Therefore, breast implants are not perfect and cannot be expected to last forever or to be without some potential problems. However, breast implants have been extensively tested, studied and used in millions of women.

The results of the vast body of information on breast implants have lead to the world-wide acceptance of silicone breast implants as an appropriate means to enhance and reconstruct the female breast.   In addition, the validity of the safety data on breast implants has lead the U.S. Food and Drug Administration to approve the use of saline-filled and silicone gel-filled implants for breast augmentation.

Breast implants are among the most extensively studied medical devices available to patients. Concerns about breast implants and breast cancer and connective tissue diseases have been addressed in many publications and forums.

Breast Implants And Breast Cancer

The Institute of Medicine reported in 2000: "Evidence clearly shows that silicone breast implants do not cause breast cancer or the recurrence of breast cancer. In fact, some studies suggest that women with breast implants have fewer new or recurring cancers."

Breast Implants And Autoimmune Diseases

Also in their 2000 report, the Institute of Medicine addressed concerns regarding breast implants and connective tissue diseases with the following statement: "there is no evidence that silicone breast implants contribute to an increase in autoimmune (connective tissue) diseases.

A review of 17 separate studies of the occurrence of connective tissue disease in the population was remarkable for the consistent finding of no elevated risk and no indication of an association of implants with disease. Evidence suggests that such diseases are no more common in women with breast implants that in women without them."

Breast Implant Safety Update

In 2011 the FDA published an update on the safety of silicone implants.  They reviewed the most recent studies on implant safety.  In addition, the recent data was compared to historical safety data.  The evidence reaffirms prior studies; that silicone gel implants are safe devices for breast augmentation and reconstruction. 

To see the report go here: FDA Update on safety of silicone breast implants - June 2011 (PDF)

Are Breast Implants Always Trouble-Free?

Though breast implants have not been shown to cause systemic disease, it is clear that implants can cause some local problems within the breast.

Some of those issues include: firm scar tissue formation around the implant (capsular contracture), deformation of the breasts, calcium deposits in the tissue around the implant, nodule formation around an implant (silicone granuloma), pain, and changes in nipple sensation.

Though these complications are not the norm and can usually be successfully managed, it is important for women to recognize these and other issues related to breast implants.

Women considering breast augmentation must recognize that breast implants add an increased level of complexity to the maintenance of the health and aesthetics of the breasts. And, that once implants have been placed, additional implant related surgery will likely be needed at some point in a woman's lifetime.

Related Topics

Capsular contracture
Capsular contracture

Capsular contracture is when the scar tissue or soft tissue "capsule" that normally forms around the implant tightens and squeezes the breast implant. Capsular contracture is more common following infection, hematoma (bleeding and blood clot formation around the implant), and seroma (fluid around the implant). Symptoms range from firmness and mild discomfort to pain, distortion of the breast, palpability of the implant, and/or displacement of the implant.

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